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7,863 catalysts · 3,223 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k

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  • 8k filing3,223
  • grant1,368
  • device adverse event1,000
  • approval615
  • earnings582
  • device 510k476
device pma
297
  • phase 2 completion172
  • drug shortage133
  • recall121
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 23, 2026

    50
    ›Feb 26, 2026approval169d agoBUMETANIDE — FDA approvalEdenbridge Pharmaceuticals LLC

    Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 26, 2026approval169d agoPHYTONADIONE — FDA approvalPHYTONADIONE

    Sponsor: SINOTHERAPEUTICS INC. Form: TABLET. Route: ORAL

    full page →PHYTONADIONE →fda approvals ↗
    ›Feb 26, 2026approval169d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 26, 2026approval169d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

    Sponsor: TARO. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 26, 2026approval169d agoHERNEXEOS (ZONGERTINIB) — FDA approvalzongertinib

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →zongertinib →fda approvals ↗
    ›Feb 26, 2026approval169d agoRIZAFILM (RIZATRIPTAN BENZOATE) — FDA approvalNAL Pharmaceuticals Ltd

    Sponsor: GENSCO. Form: FILM. Route: ORAL

    full page →fda approvals ↗
    ›Feb 26, 2026approval169d agoDALBAVANCIN HYDROCHLORIDE — FDA approvalLong Grove Pharmaceuticals LLC

    Sponsor: LONG GROVE PHARMS. Form: POWDER. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Feb 26, 2026approval169d agoENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approvalensartinib hydrochloride

    Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL

    full page →ensartinib hydrochloride →fda approvals ↗
    ›Feb 26, 2026approval169d agoPHYTONADIONE — FDA approvalPHYTONADIONE

    Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION

    full page →PHYTONADIONE →fda approvals ↗
    ›Feb 26, 2026approval169d agoIVERMECTIN — FDA approvalIVERMECTIN

    Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

    full page →IVERMECTIN →fda approvals ↗
    ›Feb 26, 2026device 510k169d agoSibel Health, Inc. — ANNE Maternal (510k cleared)Seed Health Inc

    Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoGlobus Medical, Inc. — RIB LINK™ Fixation System (510k cleared)GLOBUS MEDICAL INC

    Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoORO Co., Ltd. — CAPRI (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoOsteonic Co., Ltd. — Aster (510k cleared)

    Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoImplanet — SWINGO-3D Lumbar Cage System (510k cleared)

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoMedacta International S.A. — GMK 3D Metal Tibial Tray Extension (510k cleared)Stemedica International S.A.

    Product code: MBH. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoKarl Storz SE & CO. KG — KARL STORZ ICG Imaging System with RUBINA® Lens (510k cleared)

    Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoShanghai AnQing Medical Instrument Co., Ltd. — InnovexView (GC146-17, GC150-20, GC155-23) (510k cleared)

    Product code: HIH. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoAidoc Medical , Ltd. — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device (510k cleared)

    Product code: QAS. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoDePuy Mitek, Inc. — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (510k cleared)

    Product code: KCT. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoCopioumed International, Inc. — Copioumed AAMI 3 Surgical Gown (510k cleared)COMPX INTERNATIONAL INC

    Product code: FYA. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoOwl Dental Lab, Inc. — Owl Night Guard (510k cleared)

    Product code: OBR. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoDisior, Ltd. — ENOS Software Guided External Fixation System (510k cleared)

    Product code: OSN. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoSpeciality Fibres and Materials Limited — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm (510k cleared)

    Product code: QSY. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device 510k169d agoEnbio Group AG — Enbio PRO (510k cleared)

    Product code: FLE. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 26, 2026device pma169d agoMedtronic, Inc. — CoreValve EnVeo Pro Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Delivery Catheter System (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoCardiovascular Systems, Inc. — Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoScibase AB — Nevisense (PMA supplement)

    Supplement type: Real-Time Process. Product code: ONV. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoIntera Oncology — lntera 3000 Hepatic Artery Infusion Pump (PMA supplement)

    Supplement type: Real-Time Process. Product code: LKK. Advisory committee: HO. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoAlcon Laboratories, Inc. — Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear (PMA supplement)Alcon Laboratories Inc

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoMicroTransponder, Inc. — Vivistim® Paired VNS System (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: QPY. Advisory committee: PM. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoETHICON, Inc. — ETHIZIA Hemostatic Patch (PMA supplement)

    Supplement type: 30-Day Notice. Product code: SGV. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoKARL STORZ Endoscopy-America, Inc. — Photodynamic Diagnostic D-Light C (PDD) System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: OAY. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026device pma169d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA)

    Product code: MJO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Feb 26, 2026grant169d agoBETH ISRAEL DEACONESS MEDICAL CENTER — THWART-TB : Testing Health Workers At Risk to advance our understanding of TB...

    AI grant. $111,645. PI: Ruvandhi Nathavitharana

    full page →nih reporter ↗
    ›Feb 26, 2026grant169d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Uncovering Morphogenetic Modularity with Data Science

    GM grant. $400,881. PI: Tomer Stern

    full page →nih reporter ↗
    ›Feb 26, 2026grant169d agoUNIVERSITY OF CALIFORNIA AT DAVIS — Multi-glycomic characterization of cell membrane and the role of glycans in p...

    GM grant. $402,051. PI: CARLITO B LEBRILLA

    full page →nih reporter ↗
    ›Feb 27, 2026approval168d agoPREZCOBIX (DARUNAVIR AND COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

    Sponsor: JANSSEN PRODS. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →fda approvals ↗
    ›Feb 27, 2026approval168d agoDILTIAZEM HYDROCHLORIDE — FDA approvalDILTIAZEM HYDROCHLORIDE

    Sponsor: MACLEODS PHARMS LTD. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →DILTIAZEM HYDROCHLORIDE →fda approvals ↗
    ›Feb 27, 2026approval168d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

    Sponsor: VALEANT LUXEMBOURG. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 27, 2026approval168d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

    Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

    full page →lurbinectedin →fda approvals ↗
    ›Feb 27, 2026approval168d agoPALYNZIQ (PEGVALIASE-PQPZ) — FDA approvalBIOMARIN PHARMACEUTICAL INC

    Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Feb 27, 2026approval168d agoCALCITRIOL — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: HUMANWELL PURACAP. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 27, 2026approval168d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

    Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Feb 27, 2026approval168d agoDULOXETINE HYDROCHLORIDE — FDA approvalduloxetine hydrochloride DR

    Sponsor: ALMATICA. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

    full page →duloxetine hydrochloride DR →fda approvals ↗
    ›Feb 27, 2026approval168d agoIZERVAY (AVACINCAPTAD PEGOL SODIUM) — FDA approvalavacincaptad pegol sodium

    Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL

    full page →avacincaptad pegol sodium →fda approvals ↗
    ›Feb 27, 2026approval168d agoREBLOZYL (LUSPATERCEPT-AAMT) — FDA approvalluspatercept

    Sponsor: CELGENE CORP. Form: POWDER. Route: SUBCUTANEOUS

    full page →luspatercept →fda approvals ↗
    ›Feb 27, 2026approval168d agoYUVIWEL (NAVEPEGRITIDE) — FDA approvalnavepegritide

    Sponsor: ASCENDIS. Form: POWDER. Route: SUBCUTANEOUS

    full page →navepegritide →fda approvals ↗
    ›Feb 27, 2026approval168d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

    Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

    full page →tedizolid phosphate →fda approvals ↗
    ›Feb 27, 2026approval168d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

    Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →somatriptan albumin bound LA →fda approvals ↗
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    $CIX23.11+2.78%
    $GMED79.93+1.27%
    $RDHL0.7390+6.64%
    $RDHL0.7390+6.64%
    $JAZZ248.94+0.39%
    $GILD135.87+0.07%
    $MDT90.76+0.09%
    $GILD135.87+0.07%
    $BMRN70.24+0.99%
    $SIGY0.04000.00%
    $NVO46.39-1.65%